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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION BURETROL SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number FMC9651P
Device Problems Disconnection (1171); Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the burette chamber cap of a buretrol iv solution administration set had separated from the device and was missing.It was determined that the cap was missing during priming prior to patient use.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection was performed which observed that the cap of the burette chamber was missing.The reported condition was verified.The cause of the condition was related to a bonding application issue during the manufacturing process.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
BURETROL SOLUTION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10906901
MDR Text Key218927401
Report Number1416980-2020-07386
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 12/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberFMC9651P
Device Lot Number19K26T417
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2020
Date Manufacturer Received12/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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